Last updated: December 19, 2023
Sponsor: Centre Hospitalier Emile Roux
Overall Status: Active - Recruiting
Phase
N/A
Condition
Chronic Pain
Pain
Treatment
Standard pain management combined with sleep disorder management
Clinical Study ID
NCT06052384
RIPH2_PEREZ_DOLOREPIT
2022-A00919-34
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- First consultation at the pain management center
- Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain musthave several of the following characteristics:
- Persistence or recurrence
- Duration beyond what is usual for the presumed initial cause, especially if thepain has been evolving for more than 3 months;
- Inadequate response to treatment;
- Important and progressive deterioration of the patient's functional andinterpersonal abilities in activities of daily living at home, school, or workdue to the pain.
- Patients with chronic primary pain (according to the typology defined by theInternational Classification of Diseases-11) and classified into one of the 4following categories:
- Chronic generalized pain
- Complex regional pain syndrome
- Chronic primary headache or orofacial pain
- Chronic primary musculoskeletal pain
- Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the scoremust be available (for randomization purposes)
- Have access to an internet connection as a self-administered questionnaire is tocomplete online, and at least have access to the online platform for CBT treatment ifinsomnia is detected
- Affiliation to a French social security system
- Free informed consent
Exclusion
Exclusion Criteria:
- Patients undergoing cancer treatment or who have completed treatment within the last 2years
- Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosingspondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease,myositis, Still's disease, lupus erythematosus, etc.)
- Immunocompromised patient
- Patient with severe psychiatric pathology that does not allow study follow-up (at thediscretion of the investigator)
- Patient already treated for a sleep disorder by a sleep specialist (the onlyprescription of hypnotics is not considered as a criterion of non-inclusion)
- Patient follow-up difficult (for geographic motives or other reasons)
- Patient under judicial protection of incapable adults or guardianship
- Refusal to participate in the research
Study Design
Total Participants: 664
Treatment Group(s): 1
Primary Treatment: Standard pain management combined with sleep disorder management
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
April 30, 2027
Connect with a study center
Centre Hospitalier Emile Roux
Le Puy-en-Velay,
FranceActive - Recruiting
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